Trial Outcomes & Findings for 6-week Trial of the Efficacy and Safety of Asenapine Compared to Placebo in Participants With an Acute Exacerbation of Schizophrenia (P06124) (NCT NCT01098110)

NCT ID: NCT01098110

Last Updated: 2024-06-20

Results Overview

PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. Change from baseline values that are negative represent an improvement in symptoms.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 532 participants
• Primary outcome timeframe: Baseline and Day 42
• Results posted on: 2024-06-20

Participant Flow

Participant milestones

Measure	Asenapine 5 mg BID Participants received a 5 mg asenapine fast dissolving tablet twice daily (BID) for 6 weeks.	Asenapine 10 mg BID Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID Participants received matching placebo BID for 6 weeks.
Overall Study STARTED	176	182	174
Overall Study Treated	175	181	174
Overall Study COMPLETED	114	109	80
Overall Study NOT COMPLETED	62	73	94

Reasons for withdrawal

Measure	Asenapine 5 mg BID Participants received a 5 mg asenapine fast dissolving tablet twice daily (BID) for 6 weeks.	Asenapine 10 mg BID Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID Participants received matching placebo BID for 6 weeks.
Overall Study Withdrawal by Subject	14	24	19
Overall Study Adverse Event	30	32	43
Overall Study Lack of Efficacy	13	9	27
Overall Study Other	4	7	5
Overall Study Untreated	1	1	0

Baseline Characteristics

6-week Trial of the Efficacy and Safety of Asenapine Compared to Placebo in Participants With an Acute Exacerbation of Schizophrenia (P06124)

Baseline characteristics by cohort

Measure	Asenapine 5 mg BID n=175 Participants Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.	Asenapine 10 mg BID n=181 Participants Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID n=174 Participants Participants received matching placebo BID for 6 weeks.	Total n=530 Participants Total of all reporting groups
Age, Continuous	41.41 Years STANDARD_DEVIATION 11.00 • n=5 Participants	41.72 Years STANDARD_DEVIATION 11.10 • n=7 Participants	41.11 Years STANDARD_DEVIATION 12.27 • n=5 Participants	41.42 Years STANDARD_DEVIATION 11.45 • n=4 Participants
Sex: Female, Male Female	100 Participants n=5 Participants	82 Participants n=7 Participants	93 Participants n=5 Participants	275 Participants n=4 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	99 Participants n=7 Participants	81 Participants n=5 Participants	255 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Day 42

Population: All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the last observation carried forward (LOCF) method.

PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. Change from baseline values that are negative represent an improvement in symptoms.

Outcome measures

Measure	Asenapine 5 mg BID n=173 Participants Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.	Asenapine 10 mg BID n=178 Participants Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID n=174 Participants Participants received matching placebo BID for 6 weeks.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score.	-12.24 Score on a scale Interval -15.28 to -9.2	-14.17 Score on a scale Interval -17.12 to -11.22	-0.95 Score on a scale Interval -3.95 to 2.06

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.

PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.

Outcome measures

Measure	Asenapine 5 mg BID n=173 Participants Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.	Asenapine 10 mg BID n=178 Participants Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID n=174 Participants Participants received matching placebo BID for 6 weeks.
Change From Baseline in PANSS Positive Symptom Score.	-4.31 Score on a scale Interval -5.29 to -3.33	-4.63 Score on a scale Interval -5.59 to -3.68	-0.85 Score on a scale Interval -1.82 to 0.13

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. One participant from the 5 mg BID arm was missing a post-baseline measurement. Dropout or missing data are imputed by the LOCF method.

PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. . An improvement in symptoms is represented by change from baseline values that are negative.

Outcome measures

Measure	Asenapine 5 mg BID n=172 Participants Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.	Asenapine 10 mg BID n=178 Participants Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID n=174 Participants Participants received matching placebo BID for 6 weeks.
Change From Baseline in PANSS Negative Symptom Score.	-2.72 Score on a scale Interval -3.5 to -1.93	-3.27 Score on a scale Interval -4.03 to -2.51	-0.24 Score on a scale Interval -1.02 to 0.53

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.

PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale is the sum of the scores for all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms.. An improvement in symptoms is represented by change from baseline values that are negative.

Outcome measures

Measure	Asenapine 5 mg BID n=173 Participants Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.	Asenapine 10 mg BID n=178 Participants Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID n=174 Participants Participants received matching placebo BID for 6 weeks.
Change From Baseline in PANSS General Psychopathology Score.	-5.26 Score on a scale Interval -6.81 to -3.72	-6.34 Score on a scale Interval -7.84 to -4.83	0.19 Score on a scale Interval -1.34 to 1.72

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.

PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score is the sum of the scores for all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.

Outcome measures

Measure	Asenapine 5 mg BID n=173 Participants Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.	Asenapine 10 mg BID n=178 Participants Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID n=174 Participants Participants received matching placebo BID for 6 weeks.
Change From Baseline in PANSS Marder Factor Positive Symptom Score.	-4.78 Score on a scale Interval -5.75 to -3.81	-5.03 Score on a scale Interval -5.98 to -4.09	-1.37 Score on a scale Interval -2.33 to -0.41

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.

PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.

Outcome measures

Measure	Asenapine 5 mg BID n=173 Participants Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.	Asenapine 10 mg BID n=178 Participants Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID n=174 Participants Participants received matching placebo BID for 6 weeks.
Change From Baseline in PANSS Marder Factor Negative Symptom Score.	-2.77 Score on a scale Interval -3.58 to -1.96	-3.35 Score on a scale Interval -4.14 to -2.55	-0.41 Score on a scale Interval -1.21 to 0.4

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. One participant from the 5 mg BID arm was missing a post-baseline measurement. Dropout or missing data are imputed by the LOCF method.

PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.

Outcome measures

Measure	Asenapine 5 mg BID n=172 Participants Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.	Asenapine 10 mg BID n=178 Participants Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID n=174 Participants Participants received matching placebo BID for 6 weeks.
Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score.	-2.48 Score on a scale Interval -3.23 to -1.73	-2.85 Score on a scale Interval -3.57 to -2.12	0.24 Score on a scale Interval -0.5 to 0.97

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method

PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.

Outcome measures

Measure	Asenapine 5 mg BID n=173 Participants Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.	Asenapine 10 mg BID n=178 Participants Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID n=174 Participants Participants received matching placebo BID for 6 weeks.
Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score.	-0.77 Score on a scale Interval -1.35 to -0.18	-1.40 Score on a scale Interval -1.97 to -0.84	0.86 Score on a scale Interval 0.28 to 1.43

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.

PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative.

Outcome measures

Measure	Asenapine 5 mg BID n=173 Participants Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.	Asenapine 10 mg BID n=178 Participants Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID n=174 Participants Participants received matching placebo BID for 6 weeks.
Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score.	-1.55 Score on a scale Interval -2.01 to -1.08	-1.67 Score on a scale Interval -2.12 to -1.22	-0.13 Score on a scale Interval -0.59 to 0.32

SECONDARY outcome

Timeframe: Day 42

Population: All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.

PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The PANSS total score was determined at baseline and then at Day 42, and a participant with a 30% or greater reduction from baseline in PANSS total score at Day 42 was considered a PANSS responder.

Outcome measures

Measure	Asenapine 5 mg BID n=173 Participants Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.	Asenapine 10 mg BID n=178 Participants Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID n=174 Participants Participants received matching placebo BID for 6 weeks.
Percentage of Participants Who Were PANSS Responders.	39.3 Percentage of participants Interval 32.0 to 47.0	43.8 Percentage of participants Interval 36.4 to 51.4	20.7 Percentage of participants Interval 14.9 to 27.5

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.

The CGI-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Change from baseline values that are negative represent an improvement in symptoms.

Outcome measures

Measure	Asenapine 5 mg BID n=173 Participants Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.	Asenapine 10 mg BID n=178 Participants Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID n=174 Participants Participants received matching placebo BID for 6 weeks.
Change From Baseline in Clinical Global Impressions -Severity of Illness (CGI-S) Score.	-0.69 Score on a scale Interval -0.86 to -0.52	-0.77 Score on a scale Interval -0.94 to -0.61	-0.18 Score on a scale Interval -0.35 to -0.01

SECONDARY outcome

Timeframe: Day 42

Population: All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method.

The CGI-I is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-I score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. The CGI-I score was assessed at baseline and Day 42. Compared to the baseline measurement, a CGI-I responder had a score at Day 42 of 3 (minimally improved), 2 (much improved) or 1 (very much improved).

Outcome measures

Measure	Asenapine 5 mg BID n=173 Participants Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.	Asenapine 10 mg BID n=178 Participants Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID n=174 Participants Participants received matching placebo BID for 6 weeks.
Percentage of Participants Who Were Clinical Global Impressions - Improvement (CGI-I) Responders.	63.6 Percentage of participants Interval 55.9 to 70.8	70.2 Percentage of participants Interval 62.9 to 76.8	41.4 Percentage of participants Interval 34.0 to 49.1

Adverse Events

Asenapine 5 mg BID

Serious events: 10 serious events

Other events: 96 other events

Deaths: 0 deaths

Asenapine 10 mg BID

Serious events: 5 serious events

Other events: 110 other events

Deaths: 0 deaths

Placebo BID

Serious events: 13 serious events

Other events: 89 other events

Deaths: 0 deaths

Serious adverse events

Measure	Asenapine 5 mg BID n=175 participants at risk Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.	Asenapine 10 mg BID n=181 participants at risk Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID n=174 participants at risk Participants received matching placebo BID for 6 weeks.
Cardiac disorders Sinus Bradycardia	0.00% 0/175 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.55% 1/181 • Number of events 1 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.00% 0/174 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Gastrointestinal disorders Vomiting	0.57% 1/175 • Number of events 1 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.00% 0/181 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.00% 0/174 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/175 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.00% 0/181 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.57% 1/174 • Number of events 1 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/175 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.00% 0/181 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.57% 1/174 • Number of events 1 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Nervous system disorders Epilepsy	0.00% 0/175 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.00% 0/181 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.57% 1/174 • Number of events 1 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Nervous system disorders Subarachnoid Hemorrhage	0.57% 1/175 • Number of events 1 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.00% 0/181 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.00% 0/174 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Psychiatric disorders Agitation	0.00% 0/175 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.00% 0/181 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.57% 1/174 • Number of events 1 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Psychiatric disorders Schizophrenia	4.6% 8/175 • Number of events 8 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	2.2% 4/181 • Number of events 4 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	4.6% 8/174 • Number of events 8 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Psychiatric disorders Schizophrenia, paranoid type	0.00% 0/175 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.00% 0/181 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.57% 1/174 • Number of events 1 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Psychiatric disorders Suicide attempt	0.00% 0/175 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.00% 0/181 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.57% 1/174 • Number of events 1 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Skin and subcutaneous tissue disorders Rash	0.00% 0/175 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.55% 1/181 • Number of events 1 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	0.00% 0/174 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication

Other adverse events

Measure	Asenapine 5 mg BID n=175 participants at risk Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.	Asenapine 10 mg BID n=181 participants at risk Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.	Placebo BID n=174 participants at risk Participants received matching placebo BID for 6 weeks.
Gastrointestinal disorders Constipation	5.7% 10/175 • Number of events 10 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	7.2% 13/181 • Number of events 15 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	6.3% 11/174 • Number of events 12 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Gastrointestinal disorders Hypoaesthesia oral	10.9% 19/175 • Number of events 20 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	9.4% 17/181 • Number of events 18 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	3.4% 6/174 • Number of events 6 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Infections and infestations Nasopharyngitis	7.4% 13/175 • Number of events 15 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	6.1% 11/181 • Number of events 13 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	4.6% 8/174 • Number of events 8 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Investigations Blood creatine phosphokinase increased	1.7% 3/175 • Number of events 4 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	6.6% 12/181 • Number of events 12 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	2.3% 4/174 • Number of events 4 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Nervous system disorders Akathisia	11.4% 20/175 • Number of events 22 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	10.5% 19/181 • Number of events 19 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	5.2% 9/174 • Number of events 9 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Nervous system disorders Dizziness	4.0% 7/175 • Number of events 8 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	9.4% 17/181 • Number of events 17 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	2.9% 5/174 • Number of events 5 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Nervous system disorders Extrapyramidal disorder	5.1% 9/175 • Number of events 9 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	7.7% 14/181 • Number of events 16 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	1.7% 3/174 • Number of events 3 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Nervous system disorders Headache	6.3% 11/175 • Number of events 12 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	5.5% 10/181 • Number of events 12 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	6.3% 11/174 • Number of events 12 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Nervous system disorders Somnolence	9.7% 17/175 • Number of events 17 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	12.2% 22/181 • Number of events 23 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	1.7% 3/174 • Number of events 3 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Psychiatric disorders Insomnia	9.7% 17/175 • Number of events 18 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	7.7% 14/181 • Number of events 16 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	12.1% 21/174 • Number of events 23 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication
Psychiatric disorders Schizophrenia	8.6% 15/175 • Number of events 15 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	13.8% 25/181 • Number of events 25 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication	24.1% 42/174 • Number of events 44 • Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs Participants who received at least one dose of trial medication

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator agrees to provide the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts, and to review and comment on the data analysis and presentation.
• Publication restrictions are in place

Restriction type: OTHER